| Grant number: | 19/03320-2 |
| Support Opportunities: | Regular Research Grants |
| Duration: | May 01, 2019 - April 30, 2022 |
| Field of knowledge: | Health Sciences - Dentistry - Oral and Maxillofacial Surgery |
| Principal Investigator: | Kristianne Porta Santos Fernandes |
| Grantee: | Kristianne Porta Santos Fernandes |
| Host Institution: | Universidade Nove de Julho (UNINOVE). Campus Vergueiro. São Paulo , SP, Brazil |
| Associated researchers: | Eduardo Vasques da Fonseca ; Sandra Kalil Bussadori |
Abstract
The surgical disjunction of the maxilla in indicated for the treatment of the transverse maxillary deficiency in adults, especially in cases of a large discrepancy in width between the maxilla and mandible. This surgery is normally performed in a hospital and the postoperative period is accompanied by pain, edema and paresthesia, which affect a large portion of the face. Photobiomodulation (PBM) with laser has demonstrated excellent results in the postoperative period of oral surgeries, but there is a need to increase the number of application points in major surgeries, which hinders and prolongs the time of use. On the other hand, the advantages of LED devices in PBM are the ability to affect larger anatomic areas, greater safety, easy application and a lower cost. Therefore, the aim of the proposed study is to evaluate the efficacy of LED devices (facial and intraoral) regarding the control of pain, edema, paresthesia and bone repair following surgical maxillary disjunction. The secondary aims are to evaluate the degree of anxiety and occurrence of headache, earache, nausea, hematoma, lacrimation, nosebleeds, dysphagia, increase in systemic and facial temperature, use of analgesics and anti-inflammatory agents and the impact of the surgical procedure on quality of life. A randomized, controlled, double-blind clinical trial will be conducted with 72 patients 18 to 45 years of age. The procedures will be performed by three surgeons. Two examiners blinded to the allocation of the patients to the different experimental groups will perform the preoperative and postoperative evaluations and another researcher will administer PBM. Prior to each surgery, five facial measurements, a periapical radiographic exam, facial and oral sensitivity tests and an evaluation of anxiety (Beck questionnaire and determination of salivary IL-1², IL-6, TNF-± and cortisol) will be performed. Immediately after the surgeries, the participants will be randomly allocated to the active and sham PBM groups. In the active group, the participants will receive nine applications of PBM (immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days) with a facial device (57 LEDs at 660 nm and 74 at 850 nm, both with 5 mW; application of 6 J per point) and an intraoral device (3 LEDs at 660 nm, with 5 mW; 2 J applied per point). In the sham group, irradiation will be simulated. Data will be collected in periods up to 120 days after surgery, depending on the variable analyzed. A normality test will be used to determine the appropriate statistical tests for each dataset, with the level of significance set to 5%. (AU)
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